Class II — GA HEALTH COMPANY LIMITED
| Recalling firm | GA Health Company Limited |
|---|---|
| Registered facility | GA HEALTH COMPANY LIMITED (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
| Product | Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046 |
| Quantity | 93,700 units |
| Distribution | US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI. |
| Initiated | 2020-11-03 |
| Classified | 2020-12-18 |
| Terminated | 2021-09-03 |
| Recall number | Z-0644-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GA HEALTH COMPANY LIMITED (Z-0644-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86763/
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